Webinars

AMCP Webinar Recordings

These recordings are not available for health care professionals’ continuing education credit.

Post-market Examination of Biosimilars & Novel Biologics: The BBCIC 2016 Surveillance Plan

http://www.amcp.org/Newsletter.aspx?id=20690
Free to AMCP members and non-members

Recording from March 23, 2016

As biosimilars come to market, physicians and patients will have questions about the safety and effectiveness of these products, similar to what was experienced with the introduction of generics more than a generation ago.

The Biologics and Biosimilars Collective Intelligence Consortium (BBCIC) harnesses cutting-edge distributed research network technology and surveillance methods to provide the reassurance that patients and physicians want.

In this webinar, we’ll introduce our BBCIC founders and discuss our 2016 BBCIC Research Plan.

Speaker
Bernadette Eichelberger, PharmD
Program Director, Biologics and Biosimilars Collective Intelligence Consortium (BBCIC)

 

Biosimilars Surveillance: Applying the Science of Proven Data Consortium Models

http://www.amcp.org/Newsletter.aspx?id=17776
Free to AMCP members and non-members may email info@biosimilarsresourcecenter.org for more information.

Recording from March 10, 2014
The Webinar addressed the science behind data consortiums, and also look at why AMCP is engaging data consortiums, managed care specialty drug experts, researchers and industry to help launch the AMCP Biosimilars Collective Intelligence Consortium before the first biosimilars hit the market.

Speaker
Jeff Brown, PhD
Harvard Medical School and Director of Data Group for the FDA’s Mini-Sentinel project

 

FDA Webinars

 

FDA’s Overview of the Regulatory Guidance for the Development and Approval of Biosimilar Products in the US

http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/ucm428730.htm
Free

This presentation was recorded to help FDA Advisory Committee members and the public gain useful insight into the unique regulatory features that are ascribed to biosimilar products.

Speaker
Dr. Leah Christl, Ph.D,
Associate Director for Therapeutic Biologics